NCT00580788 · OUTCOME
1,25 Vitamin D
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study · Source last updated 2016-02-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- pg/ml
- Interval / dispersion
- Standard Error
- Time frame
- Baseline and Daily through day 8 then at follow-up visit
Groups in this outcome
Group 1
PTHrP(1-36) 2 picomoles/kg/hr for one week.
Group 2
PTHrP(1-36) 4 picomoles/kg/hr for one week.
Group 3
PTHrP(1-36) 5 picomoles/kg/hr for one week.
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 1 | 3 |
|---|
| Group 2 | 6 |
|---|
| Group 3 | 3 |
|---|
| Group 4 | 0 |
|---|
Reported measurements
baseline
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 34.13 | 3.03 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 45.08 | 4.24 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 39.0 | 4.09 | Not reported | Not reported | Not reported |
|---|
Day 2
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 38.40 | 5.12 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 45.88 | 1.53 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 39.77 | 2.69 | Not reported | Not reported | Not reported |
|---|
Day 3
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 30.13 | 4.57 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 36.58 | 4.17 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 36.73 | 2.75 | Not reported | Not reported | Not reported |
|---|
Day 4
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 32.23 | 2.32 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 40.38 | 4.18 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 35.17 | 2.63 | Not reported | Not reported | Not reported |
|---|
Day 5
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 32.27 | 1.80 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 46.40 | 6.12 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 32.07 | 3.79 | Not reported | Not reported | Not reported |
|---|
Day 6
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 42.77 | 4.23 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 34.90 | 4.91 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 35.37 | 2.98 | Not reported | Not reported | Not reported |
|---|
Day 7
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 40.53 | 4.38 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 37.12 | 3.58 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 31.17 | 6.84 | Not reported | Not reported | Not reported |
|---|
Day 8
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 32.37 | 3.17 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 33.43 | 3.13 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 30.63 | 4.79 | Not reported | Not reported | Not reported |
|---|
follow-up
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 40.10 | 4.01 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 45.78 | 4.72 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 36.33 | 2.11 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Num Sides
- TWO_SIDED
- non Inferiority Comment
- The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- >0.05
- p Value Comment
- The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
- ci Num Sides
- TWO_SIDED
- non Inferiority Comment
- The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- 0.01
- p Value Comment
- the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- non Inferiority Comment
- The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- >0.05
- p Value Comment
- The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
- ci Num Sides
- TWO_SIDED
- non Inferiority Comment
- The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- 0.01
- p Value Comment
- the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.03
- value
- 34.13
- group Id
- OG001
- spread
- 4.24
- value
- 45.08
- group Id
- OG002
- spread
- 4.09
- value
- 39.0
- title
- baseline
- categories
- measurements
- group Id
- OG000
- spread
- 5.12
- value
- 38.40
- group Id
- OG001
- spread
- 1.53
- value
- 45.88
- group Id
- OG002
- spread
- 2.69
- value
- 39.77
- title
- Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 4.57
- value
- 30.13
- group Id
- OG001
- spread
- 4.17
- value
- 36.58
- group Id
- OG002
- spread
- 2.75
- value
- 36.73
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 2.32
- value
- 32.23
- group Id
- OG001
- spread
- 4.18
- value
- 40.38
- group Id
- OG002
- spread
- 2.63
- value
- 35.17
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 1.80
- value
- 32.27
- group Id
- OG001
- spread
- 6.12
- value
- 46.40
- group Id
- OG002
- spread
- 3.79
- value
- 32.07
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 4.23
- value
- 42.77
- group Id
- OG001
- spread
- 4.91
- value
- 34.90
- group Id
- OG002
- spread
- 2.98
- value
- 35.37
- title
- Day 6
- categories
- measurements
- group Id
- OG000
- spread
- 4.38
- value
- 40.53
- group Id
- OG001
- spread
- 3.58
- value
- 37.12
- group Id
- OG002
- spread
- 6.84
- value
- 31.17
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 3.17
- value
- 32.37
- group Id
- OG001
- spread
- 3.13
- value
- 33.43
- group Id
- OG002
- spread
- 4.79
- value
- 30.63
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 4.01
- value
- 40.10
- group Id
- OG001
- spread
- 4.72
- value
- 45.78
- group Id
- OG002
- spread
- 2.11
- value
- 36.33
- title
- follow-up
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- pg/ml
- dispersion Type
- Standard Error
- groups
- description
- PTHrP(1-36) 2 picomoles/kg/hr for one week.
- id
- OG000
- title
- Group 1
- description
- PTHrP(1-36) 4 picomoles/kg/hr for one week.
- id
- OG001
- title
- Group 2
- description
- PTHrP(1-36) 5 picomoles/kg/hr for one week.
- id
- OG002
- title
- Group 3
- description
- PTHrP(1-36) 6 picomoles/kg/hr for one week.
- id
- OG003
- title
- Group 4
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline and Daily through day 8 then at follow-up visit
- title
- 1,25 Vitamin D
- type
- SECONDARY
- unit Of Measure
- pg/ml
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Preserved source evidence · Not medical advice
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